Quality Analyst

Nypro - Maple Grove, MN

Full-time - Entry Level

Maple Grove, MN

51-100 employees

Wholesale Trade Agents and Brokers

About the position

The Quality Analyst at Jabil is responsible for ensuring compliance with established document control procedures, including managing the electronic document management system, change control system, and record retention activities. This role serves as a subject matter expert (SME) for document control processes and leads the administration of change control and deviation processes, while also providing training and support for quality-related subjects.

Responsibilities

• Administration of the document control process as the site SME.
• Site leader for administration of the change control process.
• Acts as the Change Control Administrator for review, routing, and implementation of changes.
• Reports weekly to management of change control statuses.
• Site leader for administration of deviations for review and approval.
• Interfaces with customer regarding deviations via their electronic document control system.
• Administration of training for the site.
• Document control system administration.
• Create and maintain quality training matrix.
• Conduct training for quality related subjects, i.e., GDP, Document Control, Change Control, etc.
• Administration of the Quality Record retention process, including logging, filing, and sending off-site to approved vendor.
• Develops, reviews, and implements new procedures, work instructions, and other documents as needed.
• Oversees control of documentation per ISO 13485 and 21 CFR part 820.
• Support internal, corporate, notified body, FDA, and other audits.

Requirements

• Bachelor's degree in a relevant field.
• 3 years experience in manufacturing in a quality or manufacturing engineering environment.

Nice-to-haves

• Master's degree in Mathematics/Statistics.
• Six Sigma Black Belt certification.